ZORYVE for Kids
FDA approves Arcutis' ZORYVE cream for plaque psoriasis in children.
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The U.S. Food and Drug Administration has approved ZORYVE® (roflumilast) cream 0.3% for children with plaque psoriasis as young as 2 years old, making it the first steroid-free topical treatment of its kind for toddlers. The approval, announced by GlobeNewswire, expands a drug already cleared for older children and adults into the youngest patient group yet.
ZORYVE can be applied once daily anywhere on the body, with no restrictions on how long it can be used. Arcutis Biotherapeutics CEO Frank Watanabe called the milestone a sign of the company's "commitment to delivering meaningful innovation to the youngest children and their families."
A Step-by-Step Road to Toddler Approval
ZORYVE first won FDA approval in July 2022 for adults and teens 12 and older. Arcutis then pushed younger. In October 2023, the FDA cleared it for children ages 6 to 11. Now, with the latest approval, the drug covers patients as young as 2 — completing a full sweep of the pediatric age range, according to Arcutis Biotherapeutics.
Each expansion required new clinical data. The FDA accepted a Supplemental New Drug Application for the 2-to-5 age group in March 2024. That application was backed by the MUSE trial, a study designed to measure how much of the drug enters a child's bloodstream after skin application.
MUSE Trial Showed Safe Absorption in Young Children
The MUSE study — short for Maximal Usage Systemic Exposure — tested the "worst case" scenario. Children ages 2 to 5 with psoriasis covering at least 10% of their body were enrolled. Researchers found that the amount of roflumilast absorbed into the bloodstream was consistent with levels seen in adults, according to markets.financialcontent.com.
Young children have thinner skin and absorb more from topical treatments than adults do. That makes safety data especially important. The MUSE study found no cases of application-site stinging or burning. The most common side effects were mild — upper respiratory infections in 2.1% of children and headaches in 0.9%.
Why Parents and Doctors Dreaded Steroids for Toddlers
For decades, doctors treated plaque psoriasis in young children with topical corticosteroids — standard creams that carry real risks. Long-term use can thin the skin, cause stretch marks, and suppress the body's stress hormone system. About 1% of children have plaque psoriasis, yet very few options existed for kids under 6, according to Barchart.
ZORYVE works differently. It blocks an enzyme called PDE4, which drives inflammation in the skin. It is not a steroid. Doctors can use it on sensitive areas like the face and skin folds without the usual worries. Dr. Lawrence Eichenfield, a leading pediatric dermatologist at Rady Children's Hospital in San Diego, called having a once-daily, steroid-free option "a game-changer" for this age group.
Market Edge Over Rivals and What Comes Next for Arcutis
ZORYVE now holds a temporary monopoly in the 2-to-11 pediatric psoriasis market. Its closest rival, Dermavant's VTAMA® (tapinarof), is approved only for adults. Analysts at Mizuho Securities project ZORYVE could reach over $500 million in peak sales across all psoriasis uses by 2030, according to UK Market Screener.
One hurdle remains: insurance. Many payers still require patients to try cheaper steroid creams first before approving ZORYVE. Arcutis is also pursuing approvals for other formulations, including a foam version for seborrheic dermatitis. Shares of Arcutis (Nasdaq: ARQT) rose after the announcement as investors welcomed the on-time regulatory win.
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